Nephrology
PHASE2
● Phase II
Phase 2 Study Evaluates Abatacept for Kidney Transplant Recipients
ClinicalTrials.gov
Published March 28, 2026
National Institute of Allergy and Infectious Diseases (NIAID)
NCT05917522 ↗
The National Institute of Allergy and Infectious Diseases (NIAID) is leading a Phase 2 study assessing the efficacy of biomarker-guided calcineurin inhibitor (CNI) substitution in kidney transplantation. This study, which began on December 7, 2023, aims to enroll 800 adult first-time kidney transplant recipients. The observational component of the study will evaluate the HLA-DR/DQ molecular mismatch (mMM) score as a prognostic biomarker for stratifying post-transplant alloimmune risk. Participants will be followed observationally to assess the occurrence of any alloimmune events.
Six months post-transplant, 300 eligible participants will be randomized in a 2:1 ratio to receive either abatacept or standard of care (SOC) in a nested randomized controlled trial (RCT). The primary endpoint of the RCT is the difference in renal function, specifically the change in eGFRCKD-EPI at 24 months between the two groups, adjusted for renal function at randomization. Secondary endpoints include neurocognitive function and a life participation patient-reported outcome measure (PROM). The study also aims to maintain efficacy by ensuring freedom from biopsy-proven acute rejection.
This multi-center, prospective study targets patients at clinically low risk for alloimmune memory, specifically those who are DSA negative pre-transplant. The study's primary completion is anticipated by July 2027. The results will provide insights into the potential of HLA-DR/DQ mMM scores as biomarkers and the effectiveness of abatacept in improving post-transplant outcomes.
AI Accuracy Review: 8/10
· Auto-published
Imagine receiving a kidney transplant and having a better chance at a successful recovery. This study is enrolling 800 adult first-time kidney transplant recipients to evaluate a new biomarker, the HLA-DR/DQ molecular mismatch score. This score could help doctors predict the risk of complications after the transplant. After six months, 300 eligible participants will be randomly assigned to either receive abatacept, a new treatment, or standard care. The goal is to see if switching from Tacrolimus, a common medication, to abatacept can improve kidney function and overall quality of life while still preventing rejection of the new kidney. This research is crucial because it could lead to better outcomes for patients, helping them enjoy a healthier life after transplant.
What this means for you: A new biomarker might help improve kidney transplant outcomes and patient quality of life.
View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): Kidney Transplant
Intervention(s): Abatacept (BIOLOGICAL), Standard of Care at US Transplant Centers (PROCEDURE)
800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after transplant the study will identify those who meet the eligibility criteria for the Nested Randomized Control Trial (RCT). 300 eligible subjects will be randomized 2:1 to abatacept or Standard of care (SOC) in the randomization and followed for 18 months monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM).
The primary objective of the Observational Study is to test the validity of the HLA-DR/DQ mMM score as a prognostic biomarker for stratification of post-transplant alloimmune risk. Whereas the objective of the Nested RCT is to test whether a superior outcome in kidney function (primary endpoint), as well as secondary endpoints (neurocognitive function, and life participation PROM), will be achieved in patients who are transitioned from Tacrolimus (TAC) to abatacept, while maintaining efficacy (freedom from biopsy proven acute rejection).
Detailed: Observational Study:
Enrolling 800 adult first time kidney transplant recipients. Consent and enrollment will be targeted to occur pre- or post-kidney transplant during the initial hospitalization. All subjects enrolled in the study will be followed observationally to evaluate HLA-DR/DQ molecular mismatched (mMM) as a risk-stratifying prognostic biomarker.
This prospective, multi-center, observational study of 800 kidney transplant recipients at clinically low risk for alloimmune memory (DSA negative pre-kidney transplant) who are initiated on standard of care (SOC) therapy will be used to satisfy the FDA requirement to prospectively evaluate the HLA mMM score as a prognostic biomarker for post-kidney transplant outcomes in a real-world cohort. Donor-recipient HLA-DR/DQ mMM score will be
Primary Outcome(s): In the Observational Study - The occurrence of any alloimmune event; In the Nested Randomized Control Trial (RCT) - Renal function, measured as the difference in eGFRCKD-EPI at 24-months between groups (adjusted for renal function at randomization).
Enrollment: 800 (ESTIMATED)
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start: 2023-12-07 | Primary Completion: 2027-07
